Title:  Intravaginal drug delivery system and discharge collection device

United States Patent:  6,264,638

Assignee:  Ultrafem, Inc. (Missoula, MT)

Filed:  March 28, 1997

A device is provided for reliably, comfortably and conveniently introducing agents, including drugs and other substances, into the vaginal canal. A discharge collection device is also disclosed. The disclosed devices may be formed of an elastomeric rim and a flexible film. The rim may have a non-circular cross section. The film may be collapsible into a low profile insertion configuration. The devices may be disposable, and may be constructed so as to be convenient to use, comfortable to wear internally, and reliable. Preferably, the devices are formed of thermoplastic material that softens in response to body temperature to provide improved comfort and handling.

SUMMARY OF THE INVENTION

The present invention alleviates to a great extent the disadvantages of the known substance delivery devices by providing a device which is easily compressible to a low profile insertion configuration, and which has a rim whose height is greater than its thickness, and which is arranged to provide an elastomeric outward holding force to hold it in position.

The invention may be used to deliver drugs and/or other agents topically and/or systematically through vaginal mucosa. The invention may also be used to effect intravaginal drug delivery of time released and non-time released medicants for all diseases of the vagina and other reproductive organs and any and all diseases of the entire female anatomy. The invention may be used by both menstruating and non-menstruating females. For example, for the treatment of yeast and fungal infection, medication can be delivered without interruption during menstruation. Additionally, the invention may be used for intravaginal delivery of hormones for birth control and for treatment of the female anatomy, such as during menopause.

The invention may also be used for the delivery of time released and non-time released deodorizing materials for odor prevention, for the delivery of lubrication, and for the delivery of steroids, anti-bacterial agents or any pharmacological agent, chemical, natural, or homeopathic agents. Moreover, the invention may be used for intravaginal delivery of anesthetic for local surgical procedures and for general surgical procedures and for the delivery of pain relieving medication for intermittent and chronic pain, as well as for drug delivery for pregnant women for any and all prophylaxis and illnesses particular to the fetus and/or mother-to-be.

Moreover, the present invention may be used to provide a safe sex barrier, in particular as a barrier during sexual contact to aid in the prevention of the transmission of diseases. The effectiveness of the invention in this regard may be enhanced by using a device with, or for the delivery of, non-oxynol 9 or other specific medicants.

The invention may also be used for the delivery of drugs and other substances in veterinary applications including primates other than humans and other animals.

Moreover, the invention may be employed as an aid to conception for humans, primates, and other animals. Conception can be aided by either using a collector for retaining sperm in the vaginal vault after intercourse or by placing sperm in or on a delivery device and then inserting it in the vaginal vault. This is different from and not a substitute for the medical procedures of artificial insemination that are required in certain circumstances and that are done by doctors in a clinical/hospital setting.

In one aspect of the invention, a drug delivery device is provided with a rim which has a generally rectangular cross-section and which is readily compressible into a narrow, figure-eight-shaped configuration with reduced tendency to twist or slip from between the user's fingers.

In another aspect of the invention, a flexible film is attached to the rim. The film may be used to provide surface area for drug delivery. The film may also be used to close off the device to collect fluid such as menstrual discharge. The film is preferably collapsible so as to be substantially enclosed within the rim to provide a low profile during insertion and when the device is located within the vaginal canal.

In another, separate aspect of the invention, the rim and the film may be arranged such that compressing diametrically opposed portions of the rim toward each other causes a leading portion of the rim to dip downwardly to facilitate proper insertion of the device under the cervix.

In another aspect of the present invention, the dimensions and materials of the device, including the dimensions and materials of the rim, are selected so as to optimize the device's convenience, comfort and reliability. The structure of the present invention may be sized for comfort during wearing while still being held in position by compression of the vaginal wall on the rim. The comfort is achieved in part by a rim that becomes softened or relaxed somewhat at body temperature. In a preferred embodiment of the invention, the reservoir also becomes softened at body temperature, which enhances the device's comfort.

In a preferred embodiment of the invention, a single size device may be adequate for use for a range of sizes of vaginal canals. Even when the device is used to collect menstrual fluid, a tight fit may not be needed to inhibit the passage of menstrual fluid around the rim.

Another advantage of the present invention is that, because it may be made of a material that is chemically inert and non-toxic, it should not be prone to health problems that other products with absorbent materials seem to cause. Moreover, the material of the present invention may allow for adjustment to individual shapes and afford excellent comfort while maintaining its original form. The present invention may be constructed of latex, polymers, and/or elastomers.

The present invention also relates to an intravaginal substance delivery system that has no fibrous absorbent material. The present invention also relates to an intravaginal substance delivery system that has no absorbent material.

The present invention also relates to a discharge collection device that is convenient to use, comfortable to wear, and reliable. The present invention may be used to seal off the blood environment to inhibit the growth of bacteria and entry of air and thus hinder the odor which results from the oxidation and decomposition of menstrual flow.

The present invention also relates to a specimen collector to collect blood and/or vaginal, cervical and/or uterine discharge.

Another object of the invention is to provide a device for vaginal discharge collection and/or intravaginal substance delivery, with the device being designed for economical mass production, such that the device can be conveniently disposed of after a single use.

It is yet a further object of the present invention to provide a discharge collector with any of the foregoing advantages and which provides time released and non-time released dosages of substances for both menstruating and non-menstruating females so that there will be substantially no interruption of treatment, which substance may be, for example, medication, lubrication, deodorants, hormones and analgesics.

It is another object of the present invention to provide a drug delivery device which does not require individual fitting for each user and which may be produced economically enough to be used as a disposable product.

It is yet another object of the present invention to provide a drug delivery device which is easy to insert and remove without scraping delicate tissue.

It is still another object of the present invention to provide a drug delivery device which also provides a barrier against the blood environment.

It is a further object of the present invention to provide a drug delivery device which is light weight without the bulk associated with other devices and which once inserted cannot be felt by the user so that the user is free of the annoying awareness associated with other devices.

It is another object of the present invention to provide a discharge collector with any of the foregoing advantages and which is inexpensive and therefore available to all women.

Claim 1 of 18 Claims

What is claimed is:

1. An intravaginal substance delivery system, said system comprising:

a substance for intravaginal delivery; and

a device for supporting said substance, said device being compressible from a first configuration to a low profile insertion configuration, said device including a rim for elastomerically restoring said device to said first configuration, the height of said rim being greater than the thickness of said rim; and

wherein said rim is arranged to provide an outward holding force to hold said device in position during the intravaginal delivery of said substance; and

wherein the height of said rim is no less than approximately five millimeters and no more than approximately fifteen millimeters.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.